Monitoring hepatitis C treatment uptake in Australia #2

Monitoring hepatitis C treatment

uptake in Australia Issue #2 June 20161

Reimbursements for new treatment for chronic hepatitis C during March and April 2016

A total of 6,503 patient PBS initial prescriptions were processed for reimbursement in March-April 2016.

Based on extrapolation of wholesale data to PBS reimbursement data, to account for the time lag in reporting, an estimated 13,000 – 16,250 patients initiated hepatitis C treatment in March-April 2016.

New treatments for chronic hepatitis C virus (HCV) infection, named direct acting antiviral (DAA) therapy, were recently listed on the Pharmaceutical Benefits Scheme (PBS): sofosbuvir/ledipasvir (Harvoni®), sofosbuvir/daclatasvir (Sovaldi®/Daklinza®), sofosbuvir/ribavirin (Sovaldi®/Ibavyr®), and sofosbuvir/ pegylated interferon-alfa-2a/ribavirin (Sovaldi®/ Pegysus®/ribavirin) in March 2016, and ombitasvir/ paritaprevir/ritonavir/dasabuvir (Viekira PAK®) in May 2016. Issue #2 newsletter provides the estimated total number of patients with chronic HCV who initiated treatment during March and April 2016, and detailed data on the smaller sample of patients with PBS reimbursement-based prescriptions.

1. The Kirby Institute. Monitoring hepatitis C treatment uptake in Australia (Issue 2).

The Kirby Institute, UNSW Australia, Sydney, Australia, June 2016

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Estimated total hepatitis C treatment initiations Based on extrapolation of wholesale data to PBS reimbursement data, to account for the time lag in reporting, an estimated 13,000 – 16,250 patients initiated chronic HCV treatment in March-April 2016.

Hepatitis C prescriptions processed by the PBS by jurisdiction, PBS scheme, and regimen A total of 6,503 individuals had chronic HCV DAA initial prescriptions processed by the PBS during March and April 2016, including 32% (n=2,102) in New South Wales, 32% (n=2,071) in Victoria, 21% (n=1,397) in Queensland, and 14% (n=933) in the other jurisdictions (Figure 1). Further information for individual jurisdictions are provided in Table 1.

The higher numbers for April compared to March in all jurisdictions does not represent an increase in treatment initiations, but relates to the time lag in PBS reimbursement-based reporting (it is likely that a majority of April PBS reimbursements are for patients initiated in March).

Number of prescriptions processed for reimbursement

Figure 1: Number of chronic HCV DAA initial prescriptions processed for reimbursement by the PBS during March and April 2016 in Australia, by jurisdiction 2200 2000

April

1800

March

1600

Most individuals (82%) were prescribed under the General Schedule (S85), 18% under S100 HSD Public and <1% under S100 HSD Private (Figure 2).

The 18% for S100 is an increase from the 9% in Issue #1, which may indicate a longer lag for S100 versus S85 scheme reimbursement reporting, rather than an actual increase in S100 prescribing.

Figure 2: Distribution of PBS schedule of chronic HCV DAA prescriptions during March-April 2016 in Australia 0.5% General Schedule (S85) 17.8%

S100 HSD Private S100 HSD Public 81.7%

The most commonly prescribed regimen was sofosbuvir/ledipasvir, for 61% (n=3,991), followed by sofosbuvir/daclatasvir for 35% (n=2,305), and sofosbuvir/other agents for 3% (n=207; Figure 3).

Other agents would include ribavirin, or pegylated interferon-alfa-2a/ribavirin.

Figure 3: Distribution of chronic HCV DAA regimens prescribed during March-April 2016 in Australia

1400

3%

1200

SOF + LDV

1000

SOF + DCV

800

36% SOF + Others

600 400

61%

200

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NSW

VIC

QLD

Other

2

Of individuals initiated on sofosbuvir/ledipasvir (n=3,991), 7% (n=281) were prescribed an 8-week course, 72% (n=2,887) a 12-week course, and 21% (n=823) a 24-week course.

Of individuals initiated on sofosbuvir/daclatasvir (n=2,305), 56% (n=1,295) were prescribed a 12-week course, and 44% (n=1,010) a 24-week course.

Of individuals initiated on sofosbuvir/other agents (n=207), 98% (n=203) were prescribed a 12-week course, and 2% (n=4) a 24-week course (Figure 4 and Figure 5).

The vast majority of patients prescribed sofosbuvir/ daclatasvir for 24 weeks (n=1,010; 44% of total sofosbuvir/daclatasvir) will be individuals with genotype 3 and cirrhosis. Those prescribed sofosbuvir/ledipasvir for 24 weeks (n=823; 21% of total sofosbuvir/ledipasvir) should represent individuals with genotype 1, prior treatment and cirrhosis.

Number of prescriptions processed for reimbursement

Figure 4: Distribution of chronic HCV DAA prescriptions during March-April 2016 in Australia, by treatment regimen and treatment course duration

4000

8 weeks

3500

12 weeks

3000

24 weeks

2500 2000 1500 1000 500 0

SOF + LDV

SOF + DCV

SOF + Others

Figure 5: Distribution of chronic HCV DAA prescriptions during March-April 2016 in Australia, by treatment regimen, treatment course duration and jurisdiction

Number of prescriptions processed for reimbursement

1400

8 weeks

1200

12 weeks

1000

24 weeks

800 600 400

NSW

VIC

QLD

SOF + Others

SOF + DCV

SOF + LDV

SOF + Others

SOF + DCV

SOF + LDV

SOF + Others

SOF + DCV

SOF + LDV

SOF + Others

SOF + DCV

0

SOF + LDV

200

Other

*SOF: Sofosbuvir; LDV: Ledipasvir; DCV: Daclatasvir ; NSW: New South Wales; VIC: Victoria; QLD: Queensland

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Table 1: Distribution of chronic HCV DAA prescriptions during March-April 2016 in Australia, by regimen, jurisdiction and PBS schedule (based on the number of prescriptions processed for reimbursement by PBS) NSW

VIC

QLD

SA

WA

TAS

ACT

NT

Total

LEDIPASVIR + SOFOSBUVIR

General Schedule

24 weeks

169

256

158

22

24

8

0

1

638

LEDIPASVIR + SOFOSBUVIR

S100 HSD Private

24 weeks

0

0

4

0

0

0

0

0

4

LEDIPASVIR + SOFOSBUVIR

S100 HSD Public

24 weeks

90

39

7

1

19

2

16

7

181

LEDIPASVIR + SOFOSBUVIR

General Schedule

12 weeks

742

816

606

97

125

33

9

9

2437

LEDIPASVIR + SOFOSBUVIR

S100 HSD Private

12 weeks

7

3

1

1

1

0

0

0

13

LEDIPASVIR + SOFOSBUVIR

S100 HSD Public

12 weeks

196

91

18

0

33

1

80

18

437

LEDIPASVIR + SOFOSBUVIR

General Schedule

8 weeks

105

49

74

6

4

7

4

0

249

LEDIPASVIR + SOFOSBUVIR

S100 HSD Private

8 weeks

0

0

0

0

0

0

0

0

0

LEDIPASVIR + SOFOSBUVIR

S100 HSD Public

8 weeks

11

6

0

1

0

0

14

0

32

SOFOSBUVIR + DACLATASVIR

General Schedule

24 weeks

180

314

186

37

38

15

6

0

776

SOFOSBUVIR + DACLATASVIR

S100 HSD Private

24 weeks

4

2

1

0

0

0

0

0

7

SOFOSBUVIR + DACLATASVIR

S100 HSD Public

24 weeks

106

47

11

0

19

0

26

18

227

SOFOSBUVIR + DACLATASVIR

General Schedule

12 weeks

317

353

276

50

47

14

9

1

1067

SOFOSBUVIR + DACLATASVIR

S100 HSD Private

12 weeks

6

2

0

0

0

0

0

0

8

SOFOSBUVIR + DACLATASVIR

S100 HSD Public

12 weeks

79

52

10

1

22

0

54

2

220

SOFOSBUVIR + Others

General Schedule

24 weeks

0

0

0

0

0

0

1

0

1

SOFOSBUVIR + Others

S100 HSD Private

24 weeks

1

0

0

0

0

0

0

0

1

SOFOSBUVIR + Others

S100 HSD Public

24 weeks

2

0

0

0

0

0

0

0

2

SOFOSBUVIR + Others

General Schedule

12 weeks

50

31

44

6

5

5

1

0

142

SOFOSBUVIR + Others

S100 HSD Private

12 weeks

2

0

0

0

0

0

0

0

2

SOFOSBUVIR + Others

S100 HSD Public

12 weeks

35

10

1

0

7

0

3

3

59

222

344

85

223

59

6503

Total 2102 2071 1397

*NSW: New South Wales; VIC: Victoria; QLD: Queensland; SA: South Australia; WA: Western Australia; TAS: Tasmania; ACT: Australian Capital Territory; NT: Northern Territory

Methodology Two data sources were used: PBS reports of prescriptions processed for reimbursement, and wholesale expenditure data.

PBS reports the number of prescriptions processed for reimbursement on a monthly basis. Pharmacies submit prescriptions for reimbursement 2-12 weeks (generally 2-4 weeks) after dispensing. PBS reports of the number of prescriptions are therefore subject to a time lag between drug dispensing and reimbursement submissions. This lag may also vary by pharmacy type, with potentially longer lags for public hospitalbased pharmacies (S100 scheme) compared to community-based pharmacies (S85 scheme).

The wholesale price expenditure on chronic HCV DAA drugs during March and April has been estimated

at 2.25 times wholesale price equivalent for PBS reimbursements reported for the same period.2,3 For the estimate of the number of patients initiated on HCV treatment during March-April 2016, we have used a range of 2.00-2.50 (rather than 2.25) given inherent uncertainties within this methodology.

Two assumptions have been made in reporting of the PBS reimbursement data, and in extrapolation: 1) All patients who initiated treatment in March have continued treatment in April, given that the shortest duration therapy is 8 weeks (aggregated monthly data is provided by PBS, rather than individual patient data). The aggregated numbers reported for the month of April for each regimen, duration, and scheme will therefore represent all patients initiated in both March and April; 2) The time lag is similar for patients initiated in March and April.

2. Hep C sales hit half a billion in just nine weeks. PharmaDispatch, 13 May 2016 3. Medicare catching up on HCV therapies. PharmaDispatch, 26 May 2016

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